Coronary Artery EctasiaNCIPCAENCT04265989
A New Classification and Interventional Therapy for Coronary Artery Ectasia
A study testing Single BMS, Single or Double BMS and BMS+DES in people with Coronary Artery Ectasia, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study is aim to present a new classification for coronary artery ectasia and find the best interventional therapy for different types of patients were treated and studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- Single BMS, Single or Double BMS and BMS+DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female aged ≥18 years;
- Coronary artery ectasia was confirmed by coronary CT or coronary angiography;
- The patient (or guardian) is fully aware of the study process and signs the informed consent;
- Patients were able to undergo subsequent follow-up.
Who cannot join
- Congenital coronary artery fistula;
- kawasaki disease;
- Treponema pallidum or lyme treponema;
- Marfan;
- Primary lymphoma;
- Coronary artery pseudoaneurysm;
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- Acute infectious disease or autoimmune disease;
- Hematological Disease;
- Severe liver and kidney dysfunction (AMI one week later, alanine transaminase ≥3 times the upper limit of normal value; Creatinine clearance rate ≤30ml/min or blood creatinine ≥2.5mg/dl);
- Unstable craniocerebral disease;
- Cancer;
- Severe cognitive impairment (dementia or severe mental illness);
- Patients with severe physical disabilities who cannot be followed up regularly;
- Other serious uncontrolled systemic diseases;
- Female patient who is ready to become pregnant, already pregnant or nursing;
- Contraindications to percutaneous coronary intervention (PCI) : for patients at high risk of massive bleeding in the digestive tract, intracranial and other areas, or allergic to contrast agents;
- Cannot tolerate dual antiplatelet therapy for at least 1 year;
- Age < 18 years old;
- Patients who are unable or unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Shubin Qiao, MD,PhD, +8613001237893, qsbfw@sina.com
Zhuoxuan Yang, MD,PhD, +8618811756722, 525599492@qq.com
About this study
This study is aim to present a new classification for coronary artery ectasia and find the best interventional therapy for different types of patients were treated and studied.
Read the detailed description
Coronary artery ectasia refers to a variety of reasons cause coronary artery expansion, its diameter is more than 1.5 times that of the adjacent normal coronary artery. Clinical symptoms include angina, myocardial infarction and sudden death.At present, there is no consensus on the mechanism and treatment of the disease, which may be related to the structural failure of the vessel wall and abnormal hemodynamics in the dilated segment.Most of the existing studies are case reports or single-center retrospective analysis of small samples, with low level of evidence.As a common fluid analysis method in the field of engineering, computational fluid dynamics can effectively simulate the movement and stress state of blood under reasonable model assumptions.By comparing the preoperative and postoperative data of real cases, the validity of simulation analysis results can be tested.The purpose of this study is to carry out a multi-center study combining morphological and hemodynamic factors, to propose a new classification and interventional treatment strategy for atherosclerotic coronary artery ectasia, and to provide evidence-based medical evidence for the development of treatment guidelines.
- Conditions
- Coronary Artery Ectasia
- Being tested
- Single BMS, Single or Double BMS, BMS+DES
- Keywords
- coronary artery ectasia, new classification, interventional therapy, coronary artery aneurysm
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single BMSDevice
Single bare metal stent covered the coronary artery aneurysm
Single or Double BMSDevice
Single or double layer bare metal stents covered the coronary artery aneurysm
Single or Double BMSDevice
Treated with single or double layer bare metal stents
BMS+DESDevice
Treated with bare metal stent combined with drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| coronary artery aneurysm with branches | Experimental | The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, accompany with branches origin from the aneurysm Receives: Device: Single BMS |
| coronary artery aneurysm without branches | Experimental | The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, without any branch origin from the aneurysm Receives: Device: Single or Double BMS |
| Coronary artery aneurysm with localized stenosis | Experimental | The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. localized stenosis defined as lesion to more than 70% stenosis and length less than 20 mm Receives: Device: Single or Double BMS |
| Coronary artery aneurysm with diffuse stenosis | Experimental | The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. Diffuse stenosis defined as lesion to more than 70% and length more than 20 mm Receives: Device: BMS+DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebral events (MACCEs)
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
Measured: 6 months after treatment
Secondary outcomes (3)
Changes in CCS grade
Number of participants with CCS angina pectoris grade aggravated or alleviate
Measured: 6 months after treatment
Changes in drug use
Number of participants with increased the type or dose of anti-myocardial ischemia drugs
Measured: 6 months after treatment
Changes in coronary artery aneurysm diameter
Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Nov 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery EctasiaStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Beijing Chao Yang Hospital, Peking University People's Hospital, Hebei Medical University Fourth Hospital
- Responsible party
- Principal investigator, Shubin_Qiao, China National Center for Cardiovascular Diseases
- Investigators
- Shubin Qiao, MD,PhD, Principal investigator, Fuwai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265989
- Sponsor's protocol ID
- 2019XK320064
- Acronym
- NCIPCAE
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Classification and Interventional Therapy for Coronary Artery Ectasia
- ClinicalTrials.gov ID
- NCT04265989
- Acronym / sponsor ID
- NCIPCAE / 2019XK320064
- Conditions
- Coronary Artery Ectasia
- Keywords
- coronary artery ectasia, new classification, interventional therapy, coronary artery aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Beijing Chao Yang Hospital, Peking University People's Hospital, Hebei Medical University Fourth Hospital
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aim to present a new classification for coronary artery ectasia and find the best interventional therapy for different types of patients were treated and studied.
Detailed description
Coronary artery ectasia refers to a variety of reasons cause coronary artery expansion, its diameter is more than 1.5 times that of the adjacent normal coronary artery. Clinical symptoms include angina, myocardial infarction and sudden death.At present, there is no consensus on the mechanism and treatment of the disease, which may be related to the structural failure of the vessel wall and abnormal hemodynamics in the dilated segment.Most of the existing studies are case reports or single-center retrospective analysis of small samples, with low level of evidence.As a common fluid analysis method in the field of engineering, computational fluid dynamics can effectively simulate the movement and stress state of blood under reasonable model assumptions.By comparing the preoperative and postoperative data of real cases, the validity of simulation analysis results can be tested.The purpose of this study is to carry out a multi-center study combining morphological and hemodynamic factors, to propose a new classification and interventional treatment strategy for atherosclerotic coronary artery ectasia, and to provide evidence-based medical evidence for the development of treatment guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| coronary artery aneurysm with branches | Experimental | Device: Single BMSThe diameter of coronary artery aneurysm is more than 5mm and less than 10mm, accompany with branches origin from the aneurysm |
| coronary artery aneurysm without branches | Experimental | Device: Single or Double BMSThe diameter of coronary artery aneurysm is more than 5mm and less than 10mm, without any branch origin from the aneurysm |
| Coronary artery aneurysm with localized stenosis | Experimental | Device: Single or Double BMSThe diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. localized stenosis defined as lesion to more than 70% stenosis and length less than 20 mm |
| Coronary artery aneurysm with diffuse stenosis | Experimental | Device: BMS+DESThe diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. Diffuse stenosis defined as lesion to more than 70% and length more than 20 mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant female aged ≥18 years;
- Coronary artery ectasia was confirmed by coronary CT or coronary angiography;
- The patient (or guardian) is fully aware of the study process and signs the informed consent;
- Patients were able to undergo subsequent follow-up.
Key exclusion criteria (19 listed)
- Congenital coronary artery fistula;
- kawasaki disease;
- Treponema pallidum or lyme treponema;
- Marfan;
- Primary lymphoma;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single BMSSingle bare metal stent covered the coronary artery aneurysm | Device | coronary artery aneurysm with branches |
| Single or Double BMSSingle or double layer bare metal stents covered the coronary artery aneurysm | Device | coronary artery aneurysm without branches |
| Single or Double BMSTreated with single or double layer bare metal stents | Device | Coronary artery aneurysm with localized stenosis |
| BMS+DESTreated with bare metal stent combined with drug eluting stent | Device | Coronary artery aneurysm with diffuse stenosis |
Primary outcome
Major adverse cardiac and cerebral events (MACCEs)
Time frame: 6 months after treatment
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
3 secondary outcomes
Changes in CCS grade
Time frame: 6 months after treatment
Changes in drug use
Time frame: 6 months after treatment
Changes in coronary artery aneurysm diameter
Time frame: 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubin Qiao, MD,PhD principal investigator
Fuwai Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single BMS, Single or Double BMS and BMS+DES in people with Coronary Artery Ectasia, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shubin Qiao, MD,PhD (+8613701237893, qsbfw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebral events (MACCEs) (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.